Cambrex Karlskoga

Cambrex Karlskoga

Cambrex Karlskoga features a wide range of flexible manufacturing facilities, including kilo-scale, pilot-scale, and large-scale commercial production plants.

About the plant

Working with our Karlskoga team gives you access to classic and advanced chemistry capabilities, continuous processes, and high energy chemistry expertise, whenever you need it. This site features a wide range of flexible manufacturing facilities, including kilo-scale, pilot-scale, and large-scale commercial production plants. The site develops and manufactures small molecule APIs, new chemical entities (NCEs), and intermediates from grams to tons, from clinical phase II through to commercial.

Facility Details

• 5 cGMP pilot plants
• 6 commercial scale production units
• 15 production trains
• Custom development and analytical laboratories
• cGMP kilo laboratory
• Strong regulatory history

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Building Blocks manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Phase II, Phase III, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
• DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), MFDS (South Korea)

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Batch Size / Reactor

• Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L

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Services

• Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, Storage, Distribution, GDP, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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